Contents

List of Tables

Title and Copyright Information

Preface

• The Oracle Health Sciences Safety Suite
• Documentation Accessibility
• Related Documents
• Checking My Oracle Support
• Conventions

1 Getting Started

• Product Overview
• Logging In and Out
  • Logging into the Argus Application
  • User Password Complexity Enhancement
• About the Argus Home Page
• Additional Tabs
  • Quick Launch Toolbar
  • Error Messages
  • Searching for a Case
  • Argus Insight Integration
  • Sharing a Case Series
  • Basic Features and User Actions
    • Sorting on Columns
    • Getting Help
    • Changing Your Password
    • Entering Dates
    • Using Null Flavor Data
    • Entering Multiple Language Text

2 Argus Affiliate Module

• Argus Affiliate Module Information

3 Active Cases

• Opening Active Cases

4 Local Lock Functionality

• Enabling Local Data Entry
  • Local Fields
• References for Details on Local Case Data Lock Functionality
• Changes to Report Scheduling - Auto-Scheduling
• Changes to Report Scheduling - Manual Scheduling
• Outlier Processing
• Upgrade Changes - Enabling Local Locking in Argus Safety
• Triggering Local Reports - Changes to the Report Generation Algorithm

5 Case Form

• Case Form Functions
  • Case Form Features
    • Using Password Acceptance Dialog Boxes
    • Initial Case Entry
    • Argus Safety Case Form User Preferences
  • General Tab
    • General Usage Information
    • Dynamic Workflow Indicators
    • General Information
    • Study Information
    • Reporter Information
    • Literature Information Section
  • Patient Tab
    • Patient Information
    • Patient Details
    • Event Death Details
    • Other Relevant History
    • Lab Data
    • Relevant Tests Section
    • Parent Information
  • Products Tab
    • General Usage Information
    • Drug Tab
    • The Device Tab
    • Vaccine Tab
  • Events Tab
    • General Usage Information
    • Event
    • Event Coding Section
    • Seriousness Criteria Section
    • Event Assessment
    • Product-Event Details Tab
  • Analysis Tab
    • Case Analysis Section
    • Using Auto Narrative Templates
    • Case Summary Section
    • Analysis Tab: MedWatch Info Tab
    • Analysis Tab: BfArM Info Tab
    • Analysis Tab: AFSSaPS Info Tab
  • Activities Tab
    • Activities Tab: Contact Log Section
    • Activities Tab: Action Items Section
    • Activities Tab: Routing Comments Section
    • Activities Tab: Case Lock/Close Section
  • Additional Information Tab
    • Additional Info Tab Fields and Field Descriptions
    • Searching for Documentum Links
    • Attaching Files to a Case
    • Entering Keywords
    • Attaching References to a Case
  • Regulatory Reports Tab
    • General Usage Information
    • Regulatory Report Tab Fields and Field Descriptions
    • Grouping Regulatory Reports

6 Case Actions

• Working with Cases
  • Finding and Opening Existing Cases
    • General Usage Information
    • Case Open Form Fields and Field Descriptions
    • Search Results Contents
    • Sharing a Case Series
  • Processing a Case
    • Initial Case Entry Fields and Field Descriptions
    • Booking in Cases and Entering Initial Case Information
    • Checking for Duplicates
    • Understanding Receipt Range Limits
  • Closing a Case
  • Saving a Case
  • Copying a Case
  • Using the Medical Review Function
    • Common Actions
    • Using the Medical Review Tab
    • Using Temporal View Tab
    • Using the Action Items/Additional Info Tab
  • Using the Coding Review Function
    • General Information
    • Product Information
    • Event Information
    • Death Information
    • Patient Information
    • Lab Data
    • Parent Information
    • Case Analysis
    • Common Buttons Available in Coding Review
  • Using the Action Item Tab
    • Action Item Fields and Field Descriptions
  • Using the Print Function
    • Accessing Print Medical Summary Functions
  • Printing a Case
    • Printing a Case
    • Viewing and Printing Letters
    • Viewing and Printing Attachments
    • Transmitting a Case
  • Printing a Medical Summary
  • Deleting a Case
  • Viewing Case Revisions

7 Advanced Conditions

• Advanced Conditions
  • About the Advanced Condition Screen
    • Filtering for Existing Advanced Conditions
    • Viewing Results from Existing Advanced Conditions
  • Working with Advanced Conditions
    • Creating, Viewing or Modifying Advanced Conditions
    • About the Advanced Condition Set Dialog Box
    • Additional Information about Properties
    • Sharing Advanced Conditions
    • Using Advanced Conditions
    • Creating an Advanced Condition Query Set
    • Using the Hit List Tab

8 Worklist

• About Worklist
  • General Usage Information
  • Worklist Filtering
  • Worklist Options
    • New and Open
  • Workflow Options
    • Worklist User Options
  • Worklist Action Items
    • General Usage Information
    • Query Management
    • Query Action Items
    • Search Case
    • Filter Function
  • Coding Action Items
    • Search Case
    • Filter Functions
    • Total Number of Rows
  • Contacts
    • Search Case
  • Reports
    • Search Case
    • Filter Function
    • Total Number of Rows
  • Bulk Transmit
    • To view the Bulk Transmit page
    • General Usage Information
  • Bulk Print
    • General Usage Information
  • Bulk ICSR Transmit
    • General Usage Information
  • Local Labeling
  • Coding Status
    • Search Conditions Section
    • Total Number of Rows Section
    • Coding Status Icons
  • Letters
    • Search Case Section
    • Total Number of Rows Section
  • Intake
    • Pending Tab
    • Rejected Tab

9 MedDRA Browser

• MedDRA Browser Functionality
  • Using the MedDRA Browser
    • MedDRA Browser Dialog Fields and Field Descriptions
    • MedDRA Searches and Search Results
  • Non-Current Terms Search within MedDRA Browser
  • MedDRA Recoding
    • MedDRA Recoding Logic
    • Recode MedDRA terms at the Enterprise level

10 Reports: Compliance and Aggregate Reports

• Reports
  • Compliance Reports
    • About Expedited Reports
    • About Periodic Reports
    • Creating Unscheduled Periodic Reports
    • About Submitted Reports
  • Aggregate Reports
    • General Usage Information
    • Using the System Reports Library
    • About Case Data Analysis Reports
    • About CIOMS II Line Listing Reports
    • About Case Listing Reports
    • About System Reports Library

11 Reports: Periodic Reports

• Periodic Report Types
  • Initial and Follow-up Cases in Periodic Reports
  • Storing Periodic Reports in Documentum
  • Viewing a Summary of Periodic Regulatory Reports
  • Using the Library Page
  • About CTPR: Clinical Trial Periodic Reports
    • General Usage Information
    • Common Tab Fields
  • About ICH PSUR Reports
    • General Usage Information
    • Common Tab Fields
    • CIOMS Reports
  • About US IND Periodic Reports
    • Common Fields
  • About NDA Periodic Reports
    • General Usage Information
    • Common Fields
    • Subject of Report Tab
    • Product Selection Tab
    • Inclusion Criteria Tab
    • Line Listing Tab
    • Summary Tabulations Tab
    • Scheduling Tab
    • Security Tab
  • Bulk Reporting
    • Bulk Reporting Filter Section
    • Total Number of Rows Section
    • Printing Options
    • User Options
  • Initial and Follow-up Cases in Periodic Reports

12 Reports: Bulk Reporting, ICSR Pending, and Processed ICSR Reports

• Bulk Reporting
  • Bulk Reporting Filter Section
  • Total Number of Rows Section
  • Printing Options
    • Suppress Default Printer option in Select Site Printer dialog
  • User Options
    • Lock State Header Options
    • Lock State Icon Options
• ICSR Pending Reports
  • Incoming ICSR Reports Fields
    • Button and Right-click Options
  • Pending Reports
  • Bulk Incoming ICSR Reports
  • Duplicate Search
    • Duplicate Search Dialog Box Fields and Field Descriptions
    • Duplicate Search for Incoming Review
  • View Differences Report
    • Displaying Differences
• Processed E2B Reports
  • Search Criteria Section
  • Total Number of Rows Section

13 Dashboards

• Dashboards Options
  • Open Case Summary Reports
  • Open Action Items Reports
  • Quick Signal Report
    • Quick Signal Report Fields
  • Memorized Reports
  • Increased Frequency Wizard
    • Increased Frequency Wizard
  • Expedited Report Status
    • Expedited Report Status Fields and Field Descriptions
  • Workflow Status
    • General Usage Information
    • Workflow Status Fields and Field Descriptions
  • Reports Due Soon
  • Personal Argus Status
    • Cases Assigned Section
    • Contact Log Entries Section
    • Action Items Entries
  • Case Workload

14 Utilities

• Utilities
  • Change Password
  • MedDRA Browser
  • User Login List
    • General Usage Information
  • Logs
  • View Audit Log
    • Search Conditions Section
    • Total Number of Rows Section
    • Audit Log Details Screen
  • LAM Audit Log
    • General Usage Information
  • Error Log
    • Search Conditions Section
    • Total Number of Rows Section
  • ICSR Tracking Screens
    • ICSR Transmit Status Screen
    • ICSR Receive Status
  • Case Undelete
    • Case Search Criteria Fields and Field Descriptions
    • Total Number of Rows Fields and Field Descriptions
    • General Usage Information
    • Action Justification Dialog Box Fields and Field Descriptions
  • Batch Reports
  • End of Study Unblinding
    • End-of-Study-Unblinding Dialog Box Fields and Field Descriptions
  • Clear Cache
  • Advanced Condition Library

15 Multi-Tenancy

• Introduction to Multi-tenancy
  • Multi-tenancy in Argus Safety
  • Data Segregation
    • Data Segregation by Module
    • Data Segregation impact on system level configuration items
    • Dictionaries
• Global Worklists
  • Global Worklist Tabs
    • Link to Argus Safety
  • Case Actions
  • Search Case
    • View Options
  • Global Enterprise Management
  • Add New Enterprise
  • Global User Management
    • Associate Enterprise
    • Synchronizable User Attributes
    • Configure Synchronizable Attributes
    • Modifying User Attributes
  • Application Access
    • Enterprise
    • Application